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510(k) Data Aggregation
(87 days)
ProGrip™ self-gripping polypropylene mesh is intended for use in reinforcement of abdominal wall soft tissue where weakness exists.
The ProGrip™ self-gripping polypropylene mesh rectangular and square shapes are indicated for inguinal and ventral hernia repair.
Progrip™ self-gripping polypropylene mesh is designed to allow extraperitoneal mesh placement for the repair of inguinal and ventral hernias.
Progrip™ self-gripping polypropylene mesh is made of a non-absorbable knitted monofilament polypropylene textile with resorbable polylactic acid (PLA) monofilament grips on one side. Progrip™ self-gripping polypropylene mesh is available in different shapes and sizes.
The monofilament polylactic acid grips facilitate placing and positioning the mesh, and they contribute to fixation of the mesh to the surrounding tissue for at least eight (8) weeks. The polylactic acid grips are bioresorbable. Over the time, they resorb in vivo by hydrolysis and are metabolized by the body into CO2 and H2O. Preclinical studies showed that the polylactic acid material is essentially resorbed in 36 to 50 months post-implantation. However, the resorption period depends on numerous factors including patient-related factors.
Progrip™ self-gripping polypropylene mesh is a single use device, presented in a double sterile barrier packaging (two Tyvek® pouches). The packed device is terminally sterilized by Ethylene Oxide (EtO) and placed into a commercial box or envelope with the eIFU leaflet and Patient Implant Card (PIC). All the devices are packaged unitary in a commercial box or envelope (single pack configuration: 1 unit per commercial box or envelope).
The provided document is a 510(k) premarket notification summary for a medical device (ProGrip™ Self-Gripping Polypropylene Mesh). It does not include acceptance criteria or detailed study results that would typically be reported for an AI/Software as a Medical Device (SaMD).
This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific performance acceptance criteria based on a clinical trial or a machine learning model's performance metrics. As such, the information required cannot be fully extracted based on the input document.
However, I can extract what is mentioned about performance data and the general approach:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not specify acceptance criteria in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy) that would be common for AI/SaMD devices. Instead, it describes performance testing aimed at demonstrating substantial equivalence to a predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compatibility with trocar passage (visual inspection) | Assessed via in vitro testing. |
| Physical and mechanical performance comparable to predicate | In vitro (bench) tests performed in accordance with FDA Guidance "Guidance for the Preparation of a Premarket Notification Application of a Surgical Mesh" issued March 2, 1999. |
| Results: "Results demonstrate that physical and mechanical performance of the subject are substantially equivalent to the predicate." | |
| Usability for laparoscopic approach | Human factors evaluation conducted during development. Evaluated in different configurations to address usability risks. |
- Simulated use in cadaver model: Surgeons prepared, introduced through trocar, deployed, placed, and fixated mesh. Verified product use in contact with tissue.
- Simulated use in abdominal simulator for trocar passage.
- Electronic Instructions For Use (eIFU) checked for clarity and understandability.
Compliance: "The human factors engineering process applied to the ProGrip™ Self-Gripping Polypropylene Mesh complied with the requirements of IEC 62366-1: 2015 and associated FDA guidance documents." |
| Sterilization, shelf-life, shipping, and biocompatibility are not impacted by changes | Not explicitly stated as "acceptance criteria met" but rather "not impacted by the proposed change," implying that previous validations for the predicate device still hold. |
2. Sample Size Used for the Test Set and Data Provenance
Given this is a physical medical device (surgical mesh) and the performance data primarily consists of in vitro bench testing and human factors evaluation with cadaver/simulator models, the concept of a "test set" and "data provenance" (country, retrospective/prospective) as typically applied to AI/SaMD is not directly applicable.
- Sample Size for Test Set: Not specified in terms of number of cases or patients as it's not a clinical study on patient data for software performance.
- For the in vitro bench tests, the number of samples tested for each physical/mechanical property is not provided.
- For human factors evaluation, the number of participants (surgeons) or cadaver/simulator instances is not specified.
- Data Provenance: Not applicable in the context of this device's performance evaluation as described.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided. This type of detail is usually relevant for AI/SaMD where expert annotations establish ground truth for model training and evaluation. For this physical mesh device, expert involvement is mentioned in the human factors evaluation (surgeons using the device in simulated scenarios), but not for establishing "ground truth" in the AI sense.
4. Adjudication Method for the Test Set
Not applicable for this type of device and study description. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or expert review processes to resolve disagreements when establishing ground truth for AI/SaMD.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of AI vs. Without AI Assistance
No, an MRMC comparative effectiveness study was not done. This type of study is specifically for evaluating the effectiveness of AI assistance on human reader performance, which is not relevant for a physical surgical mesh.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done
No, a standalone performance study in the context of an algorithm or AI was not done. The device is a physical mesh, not an algorithm.
7. The Type of Ground Truth Used
- For physical/mechanical tests: The "ground truth" would be established by standardized measurement techniques and validated in vitro testing methods, with comparison to the predicate device's known performance characteristics.
- For human factors evaluation: The "ground truth" was established by the observations and feedback of participating surgeons during simulated use, confirming that the device could be used effectively and safely via the laparoscopic approach. Compliance with IEC 62366-1: 2015 indicates a structured approach to usability validation rather than a "ground truth" in the AI sense.
8. The Sample Size for the Training Set
Not applicable. As this is not an AI/SaMD, there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable as there is no "training set."
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(90 days)
Transorb™ Self-Gripping Resorbable Mesh is intended to be used for the reinforcement of abdominal wall soft tissues where weakness exists in open procedures involving ventral hernia repair.
Transorb™ Self-Gripping Resorbable Mesh is designed for ventral hernia repair when placed in an extraperitoneal space by open surgical approach. Transorb™ Self-Gripping Resorbable Mesh is made of a fully resorbable bi-dimensional Poly-L-lactide, poly-trimethylene carbonate copolymer (PLLA/TMC) monofilament textile with monofilament PLLA/TMC absorbable grips on one side. Transorb™ Self-Gripping Resorbable Mesh is available in different shapes and sizes. Transorb™ Self-Gripping Resorbable Mesh is a macro-porous mesh knitted from resorbable monofilament PLLA/TMC yarns. It has been designed to reinforce soft tissues where weakness exists by providing strength and tissue integration throughout the expected healing period. Transorb™ Self-Gripping Resorbable Mesh has absorbable PLLA/TMC grips on one side that facilitate positioning and contribute to fixation. The PLLA/TMC mesh and grips degrade and resorb in vivo by hydrolysis in 36 to 60 months and are metabolized by the body into CO2 and H₂O.
The provided text describes a 510(k) premarket notification for a medical device called "Transorb™ Self-Gripping Resorbable Mesh." This submission is to demonstrate substantial equivalence to a predicate device, not to prove the device meets specific acceptance criteria for a new claim typically associated with AI/ML devices or novel therapies. Therefore, the information typically requested in your prompt regarding acceptance criteria, study types, ground truth, and expert involvement for AI/ML performance is not present in this regulatory document.
However, I can extract the performance data and "acceptance" (pass/fail) criteria as presented for the biocompatibility and bench testing components of this surgical mesh.
Here's the information based on the provided text, structured as much as possible according to your request, but acknowledging the inherent differences in regulatory submissions for a surgical mesh versus an AI/ML diagnostic tool:
1. Table of Acceptance Criteria and Reported Device Performance
For this medical device (surgical mesh), "acceptance criteria" are implied by compliance with established standards and the outcome of "Pass" for various tests. The reported device performance is that it passed these tests, thus meeting the implied criteria.
| Type of Test | Specific Test / Standard | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | ISO 10993-5 (Cytotoxicity) | Compliance with standard | Pass |
| ISO 10993-10 (Sensitization) | Compliance with standard | Pass | |
| ISO 10993-10 (Intracutaneous irritation) | Compliance with standard | Pass | |
| ISO 10993-11 (Acute systemic toxicity) | Compliance with standard | Pass | |
| ISO 10993-11 (Material mediated pyrogenicity) | Compliance with standard | Pass | |
| ISO 10993-4 (Hemolysis) | Compliance with standard | Pass | |
| ISO10993-3 (Genotoxicity: bacterial reverse mutation -Ames) | Compliance with standard | Pass | |
| ISO10993-3 (Genotoxicity: mouse lymphoma) | Compliance with standard | Pass | |
| ISO 10993-11 (Subacute systemic toxicity) | Compliance with standard | Pass | |
| ISO 10993-11 (Subchronic systemic toxicity) | Compliance with standard | Pass | |
| ISO 10993-6 (Local tissue effects - 28D - 10W - 26W - 52W - 78W) | Compliance with standard | Pass | |
| ISO 10993-9 (In vivo degradation) | Compliance with standard | Pass | |
| Bench Testing | Internal test method (Pore size: 1.4mm x 1.4mm at implantation) | Substantially equivalent to predicate | Substantially equivalent |
| ISO 3801: 1977 (Surface density) | Substantially equivalent to predicate | Substantially equivalent | |
| ISO 9073-2: 1997 (Thickness) | Substantially equivalent to predicate | Substantially equivalent | |
| ASTM 06797-15 (Bursting strength and deflection) | Substantially equivalent to predicate | Substantially equivalent | |
| ISO 13934-1: 2013 (Breaking strength and elongation at break) | Substantially equivalent to predicate | Substantially equivalent | |
| ISO 4674:1977 - method A2 (Tear strength) | Substantially equivalent to predicate | Substantially equivalent | |
| Internal test method (Suture pull-out strength) | Substantially equivalent to predicate | Substantially equivalent | |
| Animal Testing | Porcine study - Reinforcement performance (Mechanical performance, tissue repair, integration) | Demonstrated safety/performance and substantial equivalence to predicate | Demonstrated safety/performance and substantial equivalence |
| Rabbit study – Degradation/Integration (Local tissue effects, tissue integration, degradation profile) | Demonstrated safety/performance and substantial equivalence to predicate | Demonstrated safety/performance and substantial equivalence | |
| Porcine study – Gripping performance (Contribution of grips, tissue repair, integration) | Demonstrated safety/performance and substantial equivalence to predicate | Demonstrated safety/performance and substantial equivalence | |
| Human Factors | IEC 62366-1 (Usability) | Substantially equivalent for intended users, uses, environment | Substantially equivalent |
| Shelf-life | Real time studies (mechanical performance, sterile barrier) | Demonstrated 36-month shelf-life | 36 months assigned shelf-life |
Notes on Acceptance Criteria: The primary "acceptance criterion" for this 510(k) submission is to demonstrate substantial equivalence to the predicate device (TIGR® Matrix Surgical Mesh K191749), showing that differences do not raise new questions of safety or effectiveness. For biocompatibility tests, the criterion is to "Pass" the specific ISO 10993 standard. For bench tests, the conclusion is frequently stated as "substantially equivalent" to the predicate.
2. Sample Size for Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated for each test in terms of a numerical count of units or animals. The text mentions broad categories like "PLLA/TMC monofilament yarn (up to 21g)" for composition and lists different product codes/sizes (e.g., TSB1510, TSB2020, TSB3030, TSB4030) that imply various units were tested across the different evaluations. For animal studies, it mentions "large animal model" (porcine) and "rabbit study."
- Data Provenance: The studies were internal preclinical (bench and animal) tests conducted by the manufacturer or their testing partners. There is no specific country of origin mentioned for the data, beyond the manufacturer being based in France. The studies are prospective in nature, designed specifically for this submission.
3. Number of Experts and Qualifications for Ground Truth
- Not Applicable in the context of your question. This document pertains to a physical medical device (surgical mesh) and its performance in bench and animal studies, not an AI/ML device requiring expert adjudication of outputs to establish ground truth from clinical images or data. The "ground truth" here is the physical and biological reality as measured by the various test methods (e.g., breaking strength, tissue ingrowth observations).
4. Adjudication Method for Test Set
- Not Applicable for the reasons stated above. Adjudication methods like "2+1" or "3+1" are typically used to establish a consensus ground truth in clinical evaluations, especially for AI/ML diagnostic tools. For this surgical mesh, performance is measured against established scientific and engineering principles via tests (e.g., ISO standards, ASTM standards, histological examination).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially AI/ML-assisted ones) to assess the impact of the device on human reader performance. This submission is for a surgical implant, where such studies are not typically performed or required to demonstrate substantial equivalence. The document explicitly states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence."
6. Standalone (Algorithm Only) Performance Study
- No, a standalone performance study was not done. This concept is specific to AI/ML algorithms evaluated independently of human interaction. The Transorb™ mesh is a physical implant, not a software algorithm. Its performance is evaluated through physical, chemical, and biological testing, outlined as biocompatibility, bench testing, and animal studies.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is established through:
- Compliance with International Standards: For biocompatibility (ISO 10993 series) and some physical properties (e.g., ISO 3801, ISO 9073-2, ISO 13934-1, ISO 4674).
- Predicate Device Comparison: For mechanical properties and physical aspects, the device's performance is compared to the predicate device (TIGR® Matrix Surgical Mesh, K191749), with substantial equivalence being the goal.
- Histology/Pathology: For animal studies, tissue repair, tissue integration, local tissue effects, and degradation profile were assessed via histological examination.
- Direct Measurement: For parameters like pore size, surface density, thickness, bursting strength, suture pull-out strength, etc., direct measurements are taken.
8. Sample Size for the Training Set
- Not Applicable. This device is a physical surgical mesh, not an AI/ML algorithm that requires a training set. The term "training set" is not relevant in this context.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for this device, the question of how its ground truth was established is not relevant.
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